DUBLIN, Ohio–(BUSINESS WIRE)–Navidea Biopharmaceuticals (NYSE American: NAVB) (“Navidea” or the “Company”), a company specializing in the development of precision immunodiagnostic agents and immunotherapies, has today announced the results of an updated third-party asset evaluation of its rheumatoid arthritis (“RA”) diagnostic product candidate for the US and European markets.
The Company has engaged independent third-party valuation firm, LifeSci Consulting (LifeSci Partners), to perform a US-focused primary market research valuation and EU secondary market analysis of its pipeline product advanced Tc99m tilmanocept for the prediction of treatment efficacy of tumor necrosis factor alpha (“TNFα”) anti-treatment in RA. A summary of the valuation report and the assumptions on which it is based is available on the Company’s website, www.navidea.com. The US market assessment was updated from the December 2021 press release using primary information from academic rheumatologists and high-volume healthcare providers obtained through questionnaires and interviews (primary research).
The Company is continuing its Tc99m imaging evaluation program tilmanocept, a radiopharmaceutical that selectively targets the CD206 receptor expressed on activated macrophages, for indications in RA. A previously completed Phase 2B study demonstrated results supporting the hypotheses that tilmanocept Tc99m imaging can provide robust quantitative imaging in healthy controls and in patients with active RA, and that this imaging can provide an early indicator of treatment efficacy in patients with active RA. The Company’s active Phase 3 trial will evaluate the ability of tilmanocept Tc99m imaging to serve as an early predictor of treatment response in RA patients transitioning to anti-TNFα therapy.
The valuation report used cited research and assumptions believed to be consistent with industry best practice. Under the base assumptions discussed in the report, the peak of combined US and EU sales could reach $1.2 billion per year, and in the bullish scenario, the peak of annual sales in the US and in the EU could reach $2.6 billion. Comments from rheumatologists included recognition of the need for a tool that would predict treatment response. Opportunities for added value include possible extension of indications to other classes of RA treatments, registration of Tc99m tilmanocept imaging as a biomarker of activated macrophages in the joints of RA patients, and expansion into other geographical areas.
Dr. Michael Rosol, Chief Medical Officer of Navidea, said: “This report provides an updated independent assessment of the potential commercial value of tilmanocept Tc99m in the US and European markets. As with our previous release, we present this in the spirit of transparency, while giving investors insight into the company’s internal rigor in evaluating product pipeline investments. Dr. Rosol continued, “We believe we are well on our way to providing a valuable tool to address a significant unmet medical need in RA patients. Success would mean that we can provide rheumatologists and people with RA with a non-invasive, quantifiable and early indicator of whether or not anti-TNFα treatment is working. This could bring huge benefits to these patients by helping doctors get them on the right path to treatment much sooner than is possible today.
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapies. Navidea is developing several precision-targeted products based on its Manocept™ platform to improve patient care by identifying sites and pathways of disease and enabling better diagnostic accuracy, clinical decision-making and targeted treatment. Navidea’s Manocept platform relies on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of tilmanocept Tc99m, the first product developed and marketed by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing new products to market and advancing the company’s pipeline through global partnership and marketing efforts. For more information, visit www.navidea.com.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections regarding future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among others: our history of operating losses and the uncertainty of future profitability; the fact that LifeSci Partners’ evaluation of our Tc99m tilmanocept pipeline product is subject to and based on numerous assumptions regarding the commercial success of the product, the expected associated costs and the outcome of various risks, including the outcome of clinical trials, which could affect the timing of revenues, among other assumptions, that actual results may differ from these assumptions, resulting in variations from the possible results set forth in the valuation report; the final outcome of any pending litigation; our ability to successfully complete the research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals for our drug candidates; our ability to successfully commercialize our drug candidates; reliance on royalty and grant income; our ability to implement our growth strategy; anticipated trends in our business; our limited product range and distribution channels; technological advances and the development of new competitive products; our ability to comply with NYSE American continuous listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other filings with the SEC. You are urged to carefully review and consider the information contained in our filings with the SEC, which are available at http://www.sec.gov or at http://ir.navidea.com.
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